Senior Hepatology Clinical Development Lead

GSK; Camden Town; On-site; GBP 110,000 - 140,000; Full time

Job summary

GSK is seeking an Associate Director - Clinical Development to provide expert medical input at the study level for hepatology assets across Phase 1-4, leading protocol development, safety oversight, and medical monitoring within global teams.

The role requires an MD or equivalent and a strong track record in clinical development, GCP/ICH, and cross-functional collaboration to drive study decisions and regulatory deliverables.

Qualifications

• Clinical development experience in pharmaceutical/biotechnology or academic clinical research (including global interventional trials).
• Strong understanding of clinical development processes, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines and relevant regulatory frameworks.

Responsibilities

• Medical monitoring and safety oversight of hepatology trials (Phase 1-4).
• Authoring and leading development of protocols and key documents (IB, ICF, CSRs).
• Design, conduct and interpretation of studies aligned with the Clinical Development Plan (CDP).
• Lead or co-lead development of protocols and amendments for hepatology assets (Phase 1-4).
• Provide medical input to eligibility criteria, endpoints and safety monitoring plans.
• Author or oversee the authorship of protocols, IBs, ICFs, CRFs, CSRs and regulatory documents.
• Serve as study medical monitor for hepatology trials, overseeing participant safety and data quality.
• Analyze and interpret emerging clinical data to generate study-level insights in hepatology.
• Lead or support preparation of clinical and regulatory documents for hepatology studies.
• Act as member of the Clinical Matrix Team and cross-functional study teams.
• Prepare scientific content for investigator meetings and site communications.
• Ensure adherence to ICH/GCP, GSK SOPs and regulatory frameworks.
• Identify issues and help develop mitigation and process improvements in hepatology development.
• Contribute to consistent ways of working and sharing best practices across Hepatology Clinical Development.

Skills

Agile Thinking

Clinical Development

Clinical Trial Designs

Decision Making

Fostering Collaboration

Influencing Without Authority

Leadership

Matrix Leadership

Mentorship

People Management

Project Management

Risk Management

Strategic Thinking

Teamwork

Time Management

Education

Medical degree (MD) or equivalent

Bachelor's degree in life sciences or related discipline

Job description

GSK is seeking an Associate Director - Clinical Development to provide expert medical input at the study level for hepatology assets across Phase 1-4, leading protocol development, safety oversight, and medical monitoring within global teams.

The role requires an MD or equivalent and a strong track record in clinical development, GCP/ICH, and cross-functional collaboration to drive study decisions and regulatory deliverables.